Gambro Lundia AB
⚠️ Moderate Risk
FEI: 3002807039 • Lund, Skane Lan • SWEDEN
FEI Number
3002807039
Location
Lund, Skane Lan
Country
SWEDENAddress
Magistratsvagen 16, , Lund, Skane Lan, Sweden
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2018 | 78KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
| 11/7/2001 | 79LRRKIT, FIRST AID | San Francisco District Office (SAN-DO) | |
| 11/7/2001 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | San Francisco District Office (SAN-DO) | |
| 11/7/2001 | 78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Gambro Lundia AB's FDA import refusal history?
Gambro Lundia AB (FEI: 3002807039) has 4 FDA import refusal record(s) in our database, spanning from 11/7/2001 to 7/19/2018.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Gambro Lundia AB's FEI number is 3002807039.
What types of violations has Gambro Lundia AB received?
Gambro Lundia AB has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Gambro Lundia AB come from?
All FDA import refusal data for Gambro Lundia AB is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.